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FDA Recalls Blood Pressure and Heart Failure Medication

Pain pill abuse causes problems for people with real problems and can have unforeseen effects on people who take them without a proper prescription. (Contributed Photo\depositphotos)FDA Recall (Photo FDA)

This product recall is due to the detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA), made by the manufacturer – Zhejiang Huahai Pharmaceutical Co. Ltd. -- that is used in the manufacture of the subject product lots. This impurity has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification.

The products are indicated for the treatment of hypertension.

The exposure to the impurity N-nitrosodimethylamine (NDMA) that was detected in Valsartan product line presents an unacceptable carcinogenic risk to the intended patient population. To date, Prinston Pharmaceutical Inc. has not received any reports of adverse events related to this recall.

Retail pharmacies in possession of any unused products: Valsartan Tablets, 40 mg, 80mg, 160mg, and 320mg; and Valsartan-HCTZ Tablets, 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg, and 320mg/25mg, within expiration dates from Jul 2018 to Jan 2020 should immediately return the product by following the instructions below:

Solco is notifying its distributors and customers by letter and email and is arranging for return of all recalled products. Pharmacies and wholesalers that received the impacted products will receive a letter as well as a copy of this press release with their recall notification information.

Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This product recall is being made with the knowledge of the United States Food and Drug Administration.